Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562439
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Testing the Sickle Cell Caregiver Collaboration for Child Development SCCCD Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Identification and Intervention Of Developmental Delay Among Infants And Toddlers With Sickle Cell Disease Using the Sickle Cell Caregiver Collaboration for Child Development SCCCD Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCCCD
Brief Summary:
Sickle cell disease affects 100000 people and 2000 newborns each year 50 of these children have a developmental deficit 2 SD before the age of 3 Early identification of developmental deficit supports timely intervention but children with sickle cell disease are grossly underdiagnosed and undertreated The goal of the proposed study is to determine the incidence and severity of developmental deficit at 9 18 and 30 months of age among children with sickle cell disease and test a 12-month home-based caregiver intervention with this disproportionately affected population
Detailed Description:
This trial will be conducted in two phases In Aim 1 the investigators are evaluating the developmental progress of children with and without sickle cell disease SCD at 9 18 and 30 months The investigators aim to recruit a total of 100 children and their caregivers SCD 50 Comparison 50 Each childcaregiver dyad will be asked to complete 3 evaluation visits where the childs developmental progress will be evaluated and the caregiver will complete surveys related to their childs development participation and the caregivers mental health
In Aim 2 children with sickle cell disease will be randomized to receive developmental evaluations at 9 18 and 30 months alone or a 12-month home-based intervention developmental evaluations The intervention is called the Sickle Cell Collaboration for Child Development SCCCD uses the widely used Parents as Teachers curriculum and is supplemented with specific support for the caregivers related to the childs sickle cell diagnosis This pilot randomized controlled trial design is designed to 1 examine the potential effects of SCCCD on child development and caregiver well-being compared to the group with no intervention and 2 optimize trial procedures to enhance acceptability and scalability in preparation for a full-scale trial Data will be collected to explore determinants facilitators and barriers affecting participation and outcomes The investigators will recruit 50 children with sickle cell disease to this aim with the goal to have 25 children randomized to intervention Randomization will be completed using a random computer generator that can balance groups based on key factors like age sex and area deprivation index index approximating income and community resources
Participants randomized to SCCCD n25 will be invited to participate in 12 home-based intervention session over the course of 1 year 1 visit monthly with a trained parent educator They will complete the visit according to the Parents as Teachers curriculum and will provide additional discussion focused on sickle cell disease and strategies to promote child development If caregivers are uncomfortable with home-visits families will have the option to complete intervention visits in our on-site clinic space or in a preferred community location eg public library child care setting place of worship Participants in the developmental evaluation group will complete study visits as described in Aim 1
The primary outcomes are child development and caregiver acceptability of developmental screening and intervention The investigators will use implementation strategies guided by our earlier work to optimize the programs feasibility which will be measured by tracking participation and retention rates in each phase of this study Acceptability will be assessed through interviews and surveys
In Aim 2 children with sickle cell disease will be randomized to receive developmental evaluations at 9 18 and 30 months alone or a 12-month home-based intervention developmental evaluations The intervention is called the Sickle Cell Collaboration for Child Development SCCCD uses the widely used Parents as Teachers curriculum and is supplemented with specific support for the caregivers related to the childs sickle cell diagnosis This pilot randomized controlled trial design is designed to 1 examine the potential effects of SCCCD on child development and caregiver well-being compared to the group with no intervention and 2 optimize trial procedures to enhance acceptability and scalability in preparation for a full-scale trial Data will be collected to explore determinants facilitators and barriers affecting participation and outcomes The investigators will recruit 50 children with sickle cell disease to this aim with the goal to have 25 children randomized to intervention Randomization will be completed using a random computer generator that can balance groups based on key factors like age sex and area deprivation index index approximating income and community resources
Participants randomized to SCCCD n25 will be invited to participate in 12 home-based intervention session over the course of 1 year 1 visit monthly with a trained parent educator They will complete the visit according to the Parents as Teachers curriculum and will provide additional discussion focused on sickle cell disease and strategies to promote child development If caregivers are uncomfortable with home-visits families will have the option to complete intervention visits in our on-site clinic space or in a preferred community location eg public library child care setting place of worship Participants in the developmental evaluation group will complete study visits as described in Aim 1
The primary outcomes are child development and caregiver acceptability of developmental screening and intervention The investigators will use implementation strategies guided by our earlier work to optimize the programs feasibility which will be measured by tracking participation and retention rates in each phase of this study Acceptability will be assessed through interviews and surveys
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None